This example study evaluates the safety, feasibility, cellular kinetics, and preliminary anti-tumor activity of EBNK-1822H2, an illustrative allogeneic cord blood-derived dual-target CAR-NK cell product directed against CLDN18.2 and HER2, in adults with relapsed/refractory or metastatic esophageal adenocarcinoma after standard therapy. The study uses dose escalation followed by biomarker-defined expansion and prospectively records EGFR expression as an exploratory biomarker of antigen escape.
Histologically confirmed esophageal adenocarcinoma or Siewert I/II gastroesophageal junction adenocarcinoma judged biologically consistent with esophageal adenocarcinoma, unresectable/recurrent/metastatic, and not amenable to curative therapy.
Disease progressed after at least 1 prior systemic regimen for advanced disease, or the participant is intolerant of / ineligible for standard therapy. Biomarker-directed therapy must have been received or deemed inappropriate/unavailable where standard in the local setting.
At least 1 measurable lesion by RECIST v1.1.
Evidence of at least one selected target: CLDN18.2-positive by validated IHC (example threshold: membranous staining in
Esophageal squamous cell carcinoma or non-adenocarcinoma histology.
Known active CNS metastases or leptomeningeal disease; previously treated stable CNS disease may be allowed only if asymptomatic and off escalating steroids per protocol.
Prior gene-modified cellular therapy within 12 weeks, or another investigational therapy likely to confound interpretation of safety or efficacy.
Active uncontrolled infection, including uncontrolled hepatitis B, hepatitis C, HIV viremia, sepsis, or clinically significant opportunistic infection.
Single group
EBNK-1822H2 dual-target CLDN18.2/HER2 CAR-NK cells
Biological/VaccineIllustrative allogeneic cord blood-derived NK-cell product engineered to recognize CLDN18.2 and HER2.
Fludarabine
DrugLymphodepletion backbone
Cyclophosphamide
DrugLymphodepletion backbone
Incidence of dose-limiting toxicities (DLTs)
Incidence and severity of treatment-emergent adverse events
Recommended phase 2 dose
Objective response rate (ORR) by RECIST v1.1
Disease control rate (DCR) by RECIST v1.1
Duration of response
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